Metrochem Dapagliflozin Metrochem Dapagliflozin

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List of Korea Drug Master Files (KDMF) for Dapagliflozin Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Hiple Co., Ltd.
2019-09-26
Number 30-3-ND
Pharmaceutical Works Polp...
Poland
19 Pelplinska Str., 83-20...
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Farmirae Co., Ltd.
2019-04-03
Number 574-13-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
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Farmirae Co., Ltd.
2020-11-17
Number 574-17-ND
Sun Pharmaceutical Indust...
India
Plot No. Z-15, Dahej SEZ,...
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Leesung International Co., Ltd.
2019-03-18
Wed21-6-ND
Alembic Pharmaceuticals L...
India
API Division Karakhadi, P...
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Samo Pharmaceutical Co., Ltd.
2019-04-23
Wed207-40-ND
Biocon Limited
India
Plot No. 213–215 and 21...
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Dasan Pharmaceutical Co., Ltd.
2024-01-23
2243-14-ND
Dasan Pharmaceutical Co.,...
South Korea
342 Deogamsan-ro, Dogo-my...
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Mpeak Korea Co., Ltd.
2018-10-15
Number 55-8-ND
Glenmark Life Sciences Li...
India
Plot No. Z-103/Ⅰ, DAHEJ...
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Hanmi Fine Chemical Co., Ltd.
2020-04-08
1444-10-ND
Hanmi Fine Chemical Co., ...
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57 Gyeongje-ro, Siheung-s...
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Sungwoo Chemical Co., Ltd.
2019-06-18
Number 473-22-ND
HONOUR LAB LIMITED(Unit-I...
India
Plot No.4, Hetero Infrast...
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ST Pharm Co., Ltd.
2023-09-22
1301-9-ND
Hunan Jiudian Hongyang Ph...
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Tongguan Circular Economy...
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Korea Biochem Pharmaceutical Co., Ltd.
2019-08-29
2152-7-ND
Korea Biochem Pharmaceuti...
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204 Sandan-gil, Jeonui-my...
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Kookjeon Pharmaceutical Co., Ltd.
2023-09-21
2520-45-ND
Kookjeon Pharmaceutical C...
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8 Balangongdan-ro, Hyangn...
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Kyungdong Pharmaceutical Co., Ltd.
2019-08-27
1574-6-ND
Kyungdong Pharmaceutical ...
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15 Balangongdan-ro 2-gil,...
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Masung LS Co., Ltd.
2023-04-03
Wed163-30-ND
Lee Pharma Limited
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UNUST Co., Ltd.
2019-10-29
Number 496-25-ND
Lupin Limited@[Dapagliflo...
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Kookjeon Pharmaceutical Co., Ltd.
2019-08-27
Wed173-25-ND
MSN Laboratories Private ...
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Sy. No. 317, 320, 321, 32...
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ST Pharm Co., Ltd.
2020-10-29
1301-8-ND
ST Pharm Co., Ltd.
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171 Haean-ro, Danwon-gu, ...
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  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 5MG

Looking for 461432-26-8 / Dapagliflozin API manufacturers, exporters & distributors?

Dapagliflozin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dapagliflozin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dapagliflozin manufacturer or Dapagliflozin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapagliflozin manufacturer or Dapagliflozin supplier.

PharmaCompass also assists you with knowing the Dapagliflozin API Price utilized in the formulation of products. Dapagliflozin API Price is not always fixed or binding as the Dapagliflozin Price is obtained through a variety of data sources. The Dapagliflozin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dapagliflozin

Synonyms

461432-26-8, Bms-512148, Forxiga, Bms 512148, (2s,3r,4r,5s,6r)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2h-pyran-3,4,5-triol, Dagagflozin

Cas Number

461432-26-8

Unique Ingredient Identifier (UNII)

1ULL0QJ8UC

About Dapagliflozin

Dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Dapagliflozin selectively and potently inhibits SGLT2 compared to SGLT1, which is the cotransporter of glucose in the gut.

Dapagliflozin Manufacturers

A Dapagliflozin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapagliflozin, including repackagers and relabelers. The FDA regulates Dapagliflozin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapagliflozin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Dapagliflozin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dapagliflozin Suppliers

A Dapagliflozin supplier is an individual or a company that provides Dapagliflozin active pharmaceutical ingredient (API) or Dapagliflozin finished formulations upon request. The Dapagliflozin suppliers may include Dapagliflozin API manufacturers, exporters, distributors and traders.

click here to find a list of Dapagliflozin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Dapagliflozin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dapagliflozin Drug Master File in Korea (Dapagliflozin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dapagliflozin. The MFDS reviews the Dapagliflozin KDMF as part of the drug registration process and uses the information provided in the Dapagliflozin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dapagliflozin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dapagliflozin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Dapagliflozin suppliers with KDMF on PharmaCompass.

Dapagliflozin Manufacturers | Traders | Suppliers

Dapagliflozin Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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